A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years
Overview[ - collapse ][ - ]
| Purpose | A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years. |
|---|---|
| Condition | Asthma |
| Intervention | Drug: montelukast Drug: placebo (unspecified) |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00700661 |
| First Received | June 17, 2008 |
| Last Updated | September 23, 2009 |
| Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 17, 2008 |
|---|---|
| Last Updated Date | September 23, 2009 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | asthma episodes in 2 - 5 year old children [Time Frame: at 12 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | the number of treatments and duration of asthma episodes [Time Frame: at 12 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years |
|---|---|
| Official Title | A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years |
| Brief Summary | A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: montelukast One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks Other Names:
Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 500 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2002 |
| Eligibility Criteria | Inclusion Criteria: - Male or Female between and including the ages of 2 and 5 years - Patient was treated with steroids for an asthma episode in the last 3 months - Patient was admitted to the hospital or emergency room in the last 3 months - Patient is able to chew a tablet Exclusion Criteria: - Patient has been in a research study in the past 4 weeks - Patient has visited the emergency room for an asthma episode in the past week - Patients has a history of stomach, heart, liver, nerve, kidney or blood disease |
| Gender | Both |
| Ages | 2 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00700661 |
|---|---|
| Other Study ID Numbers | 2007_572 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | September 2009 |